[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493346":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":22,"responsibleParty":39,"collaborators":7,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":7,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":7,"enrollmentInfo":50,"targetDuration":7,"studyType":53,"phases":7,"briefSummary":54,"conditions":55,"keywords":7,"overallStatus":25,"whyStopped":7,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Exactech","INDUSTRY",null,[9],{"name":10,"affiliation":11,"role":12},"Abhishek Ganta, MD","NYU Langone Health","PRINCIPAL_INVESTIGATOR",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Rachael Craig","CONTACT","352-377-1140","rachael.craig@exac.com",{"name":20,"role":16,"phone":17,"phoneExt":7,"email":21},"Sandrine Angibaud","sandrine.angbaud@exac.com",[23],{"facility":24,"status":25,"city":26,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"NYU Grossman School of Medicine","RECRUITING","New York","10016","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-74.00597,40.71427,{"lat":34,"lon":33},[37],{"name":7,"role":16,"phone":38,"phoneExt":7,"email":7},"718-206-6923",{"type":40,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100493346","exactech-proximal-humerus-fracture-plate-system-post-market-clinical-follow-up-100493346",false,"NCT05703958","Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up","An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes","Inclusion Criteria:\n\n* Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate\n* Patient is willing to participate by complying with pre- and postoperative visit requirements\n* Patient is willing to agree to be followed for up to 10 years following their index surgery\n* Patient is willing and able to review and sign a study informed consent form\n\nExclusion Criteria:\n\n* Osteomyelitis of the proximal humerus or scapula\n* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis\n* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system\n* The patient is unwilling or unable to comply with the post-operative care instructions\n* Alcohol, drug, or other subtance abuse\n* Any disease state that could adversaly affect the function or longevity of the implant\n* Patient is pregnant\n* Patient is a prisoner\n* Patient has a physical or mental condition that would invalidate the results","ALL","21 Years",{"count":51,"type":52},151,"ESTIMATED","OBSERVATIONAL","The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.",[56,57,58],"Proximal Humeral Fracture","Fracture Dislocation","Non-Union Fracture","2024-10-23",{"date":61,"type":62},"2024-10-24","ACTUAL",{"date":64,"type":62},"2023-04-19",{"date":66,"type":52},"2034-09-30",{"name":5,"class":6},1]